Colonisation Efficacy of a Probiotic Chewing Gum.

November 21, 2022 updated by: BLIS Technologies Limited
To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • New Zealand
    • Otago
      • Dunedin, Otago, New Zealand, 9012
        • Recruiting
        • Blis Technologies Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In general, good health
  • Practice good oral hygiene

Exclusion Criteria:

  • Have a history of autoimmune disease or are immune compromised.
  • Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
  • People with allergies or sensitivities to dairy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes
Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.
Dietary supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)
Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Active Comparator: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes
Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.
Dietary supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)
Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Microbial colonization from baseline (Day 0) to 1 hour.
Time Frame: 1 hour post intervention.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
1 hour post intervention.
Change in Microbial colonization from baseline (Day 0) to 8 hours.
Time Frame: 8 hours post intervention.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
8 hours post intervention.
Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.
Time Frame: 8 hours past last dose following 7 days of twice daily administration of probiotic.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
8 hours past last dose following 7 days of twice daily administration of probiotic.
Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose.
Time Frame: 48 hours past last dose following 7 days of twice daily administration of probiotic.
Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
48 hours past last dose following 7 days of twice daily administration of probiotic.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BLIS Technologies Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLTCT2022/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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